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Digital Preop-planning of Total Hip Arthroplasties (PLANORTHO)

T

Toulouse University Hospital

Status

Completed

Conditions

Orthopedic Disorder

Treatments

Device: evaluation of pre-op planning using Traumacad

Study type

Interventional

Funder types

Other

Identifiers

NCT04090372
14 7426 15

Details and patient eligibility

About

Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

Full description

Total hip arthroplasties (THAs) are used to restore locomotion. More than 150,000 THAs are performed each year in France. Better outcomes require a restoration of limb lengths and anatomy. Post-operative discrepancy is the main cause of complaints and financial compensation in the US after THA. As such, the investigators aim to use preoperative digital planning using TraumaCad to optimize the restoration of the center of rotation of the hips. Preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. The TraumaCad system (Brainlab®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • being older than18 years,
  • osteoarthritis as the indication for THA

Exclusion criteria

  • THAs after femoral neck fractures,
  • revision surgery,
  • major architectural anomaly (Bone tumor, prior fracture of the pelvis, hip dysplasia),
  • patients under legal protection,
  • pregnancy or breast-feeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Control group
Active Comparator group
Description:
Control group will be assessed by standard preop planning using implants templates.
Treatment:
Device: evaluation of pre-op planning using Traumacad
TraumaCad Group
Active Comparator group
Description:
TraumaCad Group will be assessed by preop planning using Traumacad
Treatment:
Device: evaluation of pre-op planning using Traumacad

Trial contacts and locations

1

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Central trial contact

Nicolas Reina, MD

Data sourced from clinicaltrials.gov

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